Sterile kit containing silicone gel for stereotaxy

ABSTRACT

particularly a kit (K), which consists basically of a syringe ( 1 ), filled with silicone gel ( 2 ) (PMDS), which is supplied with or without a needle ( 3 ), and is appropriate for the stereotaxy procedure, showing an excellent radiological contrast and macroscopic locator in a histopathological test. The kit is completely sterile, without any type of negative or harmful interference in the nuclear medicine techniques, radiological localization of wounds and routine histological tests, and is packed in a pre-shaped recipient ( 4 ) or in a plastic blister pack ( 5 ). The kit may contain other components for use, such as gloves, cotton, gauze and similar (not demonstrated), everything made of disposable material.

This Utility Model Patent application relates to an original“SILICON-BASED DISPOSABLE STERILE KIT FOR STEREOTAXY”, particularly to akit, which basically consists of two pieces, i.e. a syringe, which ispre-filled with silicone gel for radiological contrast, and is suppliedwith or without a needle, appropriate for the test to be performed; andis duly packed in a box or plastic film. The model in question pointsout because it uses polidimetilsyloxane, the peculiar characteristics ofwhich are proved to be efficient in the elaboration of tests and/orprocedures that need radiological contrast, such as for example thelocalization of impalpable or hidden wounds.

Stereotaxy is a radiological technique, which has been already widelyused in the pre-surgical marking of impalpable neoplastic tissue wounds.

In the present STATE OF THE ART, as an infra-radiological control ofconfirmation of the area marked by the stereotaxy, iodined contrasts areused, which in spite of providing an adequate contrast on a radiologicalfilm, present some disadvantages resulting from their quick dispersionand/or absorption by human or animal tissues. Among these disadvantageswe shall point out the following most common ones:

-   -   Image without exact delimitation, without sharpness (blurry);    -   Diffusion and absorption by the tissue within a short period of        time that can make the procedure unfeasible;    -   Risk of allergic-anaphylactic reactions in iodine-sensitive        patients;    -   Impossibility of identification of the marked area, in the        macroscopic test of the surgical piece by the pathologist.

Having all these problems in mind, the inventor, after numberlessresearches, created the “SILICON-BASED DISPOSABLE STERILE KIT FORSTEREOTAXY”, which is a set consisting of a syringe that is pre-filledwith silicone gel (polidimetilsyloxane—PDMS), and is aimed at replacingthe iodine containing contrast. The kit preferentially contains a needlespecific for this kind of procedure that has specific characteristicsand does not present any problems of negative interference in thenuclear medicine techniques, radiological localization of impalpablewounds and routine histological tests. The kit in question can be alsosupplied without the aforementioned needle.

The new kit has the following main advantages, among many others:

-   -   Excellent radiological contrast;    -   Adequate and precise delimitation of the injection area, i.e.        the area marked by the stereotaxy;    -   Reduction of occurrence of possible allergic-anaphylactic        reaction in the patient;    -   Lack of local risk due to the complete excision of the marker;    -   Blocking of reflux of the radiological medicine after the        injection, avoiding this way the radioactive contamination of        the skin and the needle course in the tissue;    -   Adequate and exact macroscopic localization of the wound site by        the pathologist that increases the diagnostic efficiency during        the microscopic exam.

Dyes and other substances may be added to the silicone, either inert ornot, and other supplements, such as gauze, gloves, cotton, antiseptic,anesthetic and similar materials can be also used.

In this way, a kit with exclusive characteristics is invented, and dueto the use of silicone gel, which is completely disposable and dulypacked, the product assures reliability, agility, accuracy, safety andlow cost to the medical field professionals.

The kit will become more fully understood from the accompanyingdrawings, which are given by way of illustration only, and thus are notlimitative of the present invention, and in which:

FIG. 1: Perspective view of the components of the kit, supplied togetherwith a needle, packed in a pre-shaped package;

FIG. 2: Perspective exploded view of the kit, supplied together with aneedle;

FIG. 3: Perspective view of the components of the kit, supplied togetherwith an assembled needle;

FIG. 4: Perspective view of the components of the kit, supplied togetherwith a needle, packed in a plastic package;

FIG. 5: Perspective view of the components of the kit, without needle,packed in a pre-shaped package;

FIG. 6: Perspective exploded view of the kit without needle;

FIG. 7: Perspective view of the components of the kit without needle,packed in a plastic package.

The “SILICON-BASED DISPOSABLE STERILE KIT FOR STEREOTAXY”, object tothis Utility Model Patent application, consists essentially of a kit(K), which basically contains a syringe (1), filled with silicone gel(2) (PDMS), supplied with or without a needle (3), appropriate for theprocedure of stereotaxy that shows an excellent radiological contrastand macroscopic localization in a histopathological test, and iscompletely sterile, without any kind of negative or harmful interferencein the nuclear medicine techniques, radiological localization of thewounds and histological routine tests, and is packed in a pre-shapedrecipient (4) or in a plastic blister pack (5). The kit may containother objects, such as gloves, cotton, gauze, and similar (notdemonstrated), everything made of disposable material.

More preferentially, the kit (K) in question is composed of a syringe(1) of conventional operation, in which the piston (E) is displaced inthe body (C) of the referred to syringe (1), which is duly marked (7)and supplied with an identification bar code (8). The fitting end of theneedle (3), which is adequate for the procedure, is preferentially“luer-lock” type, or any other. The kit (K) points out because thereferred to syringe (1) is pre-filled with silicone gel (2), morespecifically, with polidimetilsyloxane. When the syringe (1) is not inuse, i.e. remains in the package (5), it remains hermetically sealed dueto the also conventional closure cap (T).

The kit (K) in question may be packed in a pre-shaped recipient (4)coated with a film (Ti), or in a plastic blister pack (5). Both packagesare completely efficient, and can be accompanied by other components foruse, such as cotton, gauze, gloves, antiseptic and anesthetic materials,etc. (not represented).

In a constructive variance, the kit (K) could also contain a syringe (1)without a needle, pre-filled with silicone gel (2), more specificallywith polidimetilsyloxane, and when the syringe (1) is not in use, i.e.remains in the package (5), it remains hermetically sealed due to thealso conventional closure cap (T).

The alternative kit (K) in question can be also packed in a pre-shapedrecipient (4) coated with a film (Ti) or in a plastic blister pack (5).Both are completely efficient, and can be also supplied together othercomponents for use, such as cotton, gauze, gloves, antiseptic andanesthetic materials, etc. (not represented).

If the same invention concept is maintained, dyes and other substances,either inert or not, may be added to the silicone gel (2).

1) “SILICON-BASED DISPOSABLE STERILE KIT FOR STEREOTAXY”, characterizedby a kit (K) consisting of a syringe (1), the needle (3) fitting end ofwhich is adequate to the procedure and is preferentially “luer-lock”type, or any other. The kit points out because the referred to syringe(1) is pre-filled with silicone gel (2), more specifically withpolidimetilsyloxane, which when not in use, i.e. remains in the package(5), remains hermetically sealed due to the also conventional closurecap (8). 2) “SILICON-BASED DISPOSABLE STERILE KIT FOR STEREOTAXY”, inaccordance with claim 1, is characterized by the package (4), which ispre-shaped (5), coated with a film (T1), or a plastic blister pack (5),and the referred to kit (K) can be also supplied with other componentsfor use, such as cotton, gauze, gloves, antiseptic and anestheticmaterials, etc. (not represented). 3) “SILICON-BASED DISPOSABLE STERILEKIT FOR STEREOTAXY”, in accordance with claim 1, is characterized by thekit (K), which can alternatively consist only of the syringe (1), whichis pre-filled with the silicone gel (2), more specifically withpolidimetilsyloxane. When the syringe (1) is not in use, i.e. remains inthe package (5), it remains hermetically sealed due to the alsoconventional closure cap (T). 4) “SILICON-BASED DISPOSABLE STERILE KITFOR STEREOTAXY”, in accordance with claim 3, is characterized by thealternative kit (K), is packed in a pre-shaped (4) recipient, coatedwith a film (T1), or in a plastic blister pack (5). Both are completelyefficient, and can be supplied together with other components for use,such as cotton, gauze, gloves, antiseptic and anesthetic materials, etc.(not represented). 5) “SILICON-BASED DISPOSABLE STERILE KIT FORSTEREOTAXY”, in accordance with claim 1 and 3, is characterized by thefact that dyes or other substances, either inert or not, can be added tothe silicone gel (2).